Opportunity Description
Job Overview
The Clinical Operations Specialist supports the planning, coordination, and delivery of clinical trials at a country level in line with ICH GCP, local regulations, and GSK standards. The role works closely with cross‑functional teams to ensure timely regulatory submissions, efficient clinical supply management, and accurate financial tracking, contributing to high‑quality and compliant study execution. Key Responsibilities
Define and support regulatory and ethics submission strategies; prepare, review, and track submission documentation Coordinate communication with regulatory authorities, ethics committees, and sites Manage clinical trial supplies and logistics, including import/export and cold chain (if applicable) Oversee vendors for supply storage, distribution, and site payments where applicable Ensure timely delivery of clinical materials and compliance with local regulations Track and manage study budgets, forecasts, and payments to sites and vendors Support a...
The Clinical Operations Specialist supports the planning, coordination, and delivery of clinical trials at a country level in line with ICH GCP, local regulations, and GSK standards. The role works closely with cross‑functional teams to ensure timely regulatory submissions, efficient clinical supply management, and accurate financial tracking, contributing to high‑quality and compliant study execution. Key Responsibilities
Define and support regulatory and ethics submission strategies; prepare, review, and track submission documentation Coordinate communication with regulatory authorities, ethics committees, and sites Manage clinical trial supplies and logistics, including import/export and cold chain (if applicable) Oversee vendors for supply storage, distribution, and site payments where applicable Ensure timely delivery of clinical materials and compliance with local regulations Track and manage study budgets, forecasts, and payments to sites and vendors Support a...
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